Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis, a Multicentre Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Acceptability of the intervention evaluated by a questionnaire
研究概览
简要总结
Canada urgently needs new ways to provide rheumatology care that improve treatment and make it easier for people to get high-quality care. E-health technology is a new and promising way to do this, but it hasn't been studied much yet in rheumatology.
The investigators will test a new way to help people with rheumatoid arthritis at four clinics in Quebec. This study will check if the new approach is easy to use, fits well into the clinics' daily routine, and if both patients and healthcare workers find it helpful and acceptable.
This new approach involves nurses helping patients check their own health from home using an online platform.
104 adults who have rheumatoid arthritis and who have had a flare-up or a change in their medication in the last three months, will participate. Some will start using the online self-monitoring tool right away for 16 months, while others will continue with their usual care for 8 months before trying the tool. During the time they use the tool, they will fill out monthly online questionnaires to check their health. A rheumatology nurse will review their answers, suggest any needed care, provide personalized health information, and be available to answer questions through messages.
This new way of care, where nurses help patients monitor their rheumatoid arthritis from home, helps make better use of limited specialist time. It's more convenient for patients, especially those who live far away, and helps meet their needs between regular doctor visits while keeping the quality of care high.
详细描述
Background: Limited access to rheumatologists in Canadian remote regions leads to delays in new-onset rheumatoid arthritis (RA) diagnosis and inadequate follow-up for disease flares or treatment adjustments. There is a critical need for innovative models of care addressing these unmet needs in resource-limited settings. E-health technologies offer a promising solution by bridging the gap between in-person rheumatology appointments. These tools can optimize the use of scarce specialist resources, enhance the continuity and quality of care, and provide greater convenience for patients-particularly in underserved or geographically isolated areas. By supporting timely interventions and patient-centered monitoring, e-health can play a vital role in improving outcomes and ensuring equitable access to care.
Objectives: This study will evaluate the acceptability and feasibility of a nurse-led telehealth remote self-monitoring model of care for patients with RA.
Primary Objective: Acceptability of a nurse-led telehealth remote self-monitoring program, defined as patient-reported perceptions of usefulness, ease of use, attitudes, and overall experience, and assessed with questionnaires and semi-structured interviews.
Secondary Objectives: Feasibility using the RE-AIM implementation framework:
- Reach: Proportion of eligible patients enrolled and comparison of participant versus non-participant characteristics.
- Effectiveness: Frequency and relevance of nurse calls, healthcare utilization, health-related quality of life, disease activity, and medication adherence.
- Adoption: Completion rate of remote monitoring questionnaires, study retention, and reasons for discontinuation.
- Implementation: Fidelity to protocol, appropriateness of alerts, subsequent actions, and timeliness of in-person visits; identify barriers and facilitators.
- Maintenance: Intention for continued use among healthcare providers and patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of rheumatoid arthritis (RA) according to the ACR 2010 criteria
- •Disease duration ≥ six months
- •Who experienced a flare defined by an increase of the clinical disease activity index (CDAI) ≥ 4.5 or a DMARDs switch or addition within the preceding three months
- •Understanding French or English
排除标准
- •Inability to consent
- •Inability to complete questionnaires
- •No Internet access
研究组 & 干预措施
Immediate intervention (for 16 months)
The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available.
干预措施: Nurse-led telehealth remote self-monitoring (Other)
Delayed intervention ( 8 months of control period followed by 8 months with the intervention)
Usual care for 8 months, consisting in rheumatology visits scheduled every 3-6 months.
Followed by the intervention for 8 months: The intervention includes nurse-led remote self-monitoring of RA, with patients completing monthly self-assessments of disease activity (RADAI), symptoms and function (PROMIS-29). Rheumatology nurses will receive alerts if monitoring suggests moderate/high disease activity and will contact participants to determine care needed. Tailored information based on PROMIS-29 answers will be sent to facilitate self-management. Asynchronous messaging with rheumatology nurses and information on RA self-management will be available.
干预措施: Nurse-led telehealth remote self-monitoring (Other)
结局指标
主要结局
Acceptability of the intervention evaluated by a questionnaire
时间窗: At 16 months
The questionnaire of patients' perceived usefulness and ease of use of the remote self-monitoring web platform will be completed by participants at 16 months, rated using a 13-item questionnaire utilizing five-point Likert scales.
Acceptability of the intervention evaluated by a qualitative analysis
时间窗: At 16 months
Semi-structured interviews with patients and providers will be completed with a purposive sample of participants (diverse with respect to age, gender, ethnicity, education, disease type and duration, employment, urban/rural) at study end. Participants will meet in groups of 8-12 for 60-90 minutes; groups will continue until saturation of themes is obtained (estimated to be 2-3 groups). Topics will include perceived acceptability, convenience, satisfaction, beliefs, perceived usefulness and ease of use, how care received met patient needs, barriers and enablers to adopting this new model of care.
次要结局
- Age category of eligible participants(Until the end of recruiting period)
- Frequency of calls to nurses(Up to the end of intervention at 16 months)
- Use of other health care services(Every 3 months over 16 months)
- Health-related quality of life evaluated by the Patient-Reported Outcomes Measurement Information System-29 questionnaire(Every 3 months over 16 months)
- Disease activity evaluated by the Clinical Disease Activity Index(Every 3 to 6 months over 16 months)
- Proportion of medication adherence(Every 3 months up to the end of intervention over 16 months)
- Completion rate of patient questionnaires for remote self-monitoring(Every month during the intervention over 16 months)
- Proportion of participants still connecting to the web platform at study end(At 16 months)
- Time spent on the web platform(Up to the end of intervention at 16 months)
- Measuring the number of alerts per patient(Up to the end of intervention at 16 months)
- Questionnaire for the evaluation of health professionals' acceptance of a new telemonitoring system(At 16 months)
- Sex category of eligible patients(Up to the end of recruiting period)
- Clinical appropriateness of alerts(Up to the end of intervention over 16 months)
- Number of nurse-patient interactions(Up to the end of intervention over 16 months)
- Reason for nurse calls(Up to the end of intervention at 16 months)